Enrollment complete in Xencor, MorphoSys’ MOR208 phase 1 trial for CLL

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and US-based Xencor, Inc. today announced the successful completion of patient enrollment in the phase 1 clinical trial evaluating MOR208. MOR208 (formerly XmAb®5574) is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, that is being developed to treat B-cell malignancies. A total of 30 patients with relapsed or refractory chronic lymphocytic leukemia (CLL/SLL) have been randomized in the open-label, multi-dose, single-arm, dose-escalation study. No dose-limiting toxicity was observed and the trial protocol was amended to include a period of extended dosing for patients responding to treatment. The phase 1 trial was designed to assess the drug's safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity. Data from the trial will become available in Q4 2012.

"We are excited about the excellent progress of the MOR208 program and are preparing the next steps of clinical development in additional B-cell malignancies to quickly assess the broader commercial potential of the molecule," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The extended treatment period we were able to include in the phase 1 study could provide us with additional data on preliminary anti-tumor activity."

"MOR208 uses our XmAb ADCC technology to enhance its B-cell depletion properties," said Bassil Dahiyat, Ph.D., Chief Executive Officer of Xencor. "The XmAb high ADCC technology has been applied to develop six antibodies that are now in clinical testing, demonstrating the technology's broad applicability."

In June 2010, MorphoSys AG and Xencor signed a worldwide exclusive license and collaboration agreement. The agreement provided MorphoSys with an exclusive worldwide license to MOR208 for the treatment of cancer and other indications. Using Xencor's XmAb Fc enhancement technology, MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer. MorphoSys will be solely responsible for further clinical development after successful completion of the phase 1 clinical trial. MorphoSys plans to initiate additional clinical trials for MOR208 in non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) in the fourth quarter of 2012.

In total, MorphoSys currently has four proprietary clinical programs ongoing, including MOR208, MOR103, a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), in RA and MS, as well as MOR202, a HuCAL antibody targeting CD38, in multiple myeloma.